Pulmonary Disease, Chronic ObstructiveNCT03474484
Calprotectin I Serum as a Diagnostic Marker
An observational study of Pulmonary Disease, Chronic Obstructive, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Lower respiratory tract infection is the most common cause of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Patients diagnosed with pneumonia in addition to an AECOPD experience more severe clinical and laboratory disease manifestations, increase in-hospital morbidity and worse outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 113 participants
- Where
- 1 siteNorway
- Study dates
- 3 Apr 2018to 14 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Department of Thoracic Medicine at Trondheim University Hospital (TUH) due to an AECOPD, age > 18years old. (EU). The patients were examined at the Emergency Unit and included in the study if they had a COPD diagnosis previously confirmed by spirometry according to the GOLD criteria and a clinically confirmed AECOPD
Who may be able to join
- clinically confirmed acute exacerbation of chronic obstructive pulmonary disorder (AECOPD)
- COPD diagnosis previously confirmed by spirometry according to the GOLD criteria.
Who cannot join
- known malignant disease
- bronchiectasis
- chronic bacterial colonisation of the airways
- treatment with an immunosuppressive drug or long-term treatment with antibiotics.
- not examined with a chest X-ray at admission
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Thoracic and Occupational Medicine
Trondheim, Trøndelag, 7006
About this study
Official title: Calprotectin I in Serum as a Diagnostic Marker of Pneumonia in Patients Hospitalised With Acute COPD Exacerbation
Lower respiratory tract infection is the most common cause of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Patients diagnosed with pneumonia in addition to an AECOPD experience more severe clinical and laboratory disease manifestations, increase in-hospital morbidity and worse outcome. Clinicians have sought for new biomarkers that together with clinical assessments can improve the diagnostic accuracy of pneumonia in patients with AECOPD.The aim of the present study is to compare the accuracy of calprotectin with procalcitonin (PCT), C-reactive protein (CRP) and white blood cell count (WBC).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Biomarkers, Sensitivity and Specificity, Clinical Deterioration
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypersensitivity, Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| np-AECOPD | Patients with evidence of acute exacerbation of chronic obstructive pulmonary disorder (AECOPD) and pulmonary infiltrate on chest X -ray at admission | |
| p-AECOPD | Patients with evidence of acute exacerbation of chronic obstructive pulmonary disorder (AECOPD) without pulmonary infiltrate on chest X -ray at admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calprotectin concentration in serum
ELISA-kit (MRP8/14 ELISA)
Measured: Change in serum concentration from baseline to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start3 Apr 2018
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Anne h. Henriksen, md phd, Study director, St Olavs Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474484
- Sponsor's protocol ID
- 20171496/REK midt
- Status last verified
- Sep 2018
- First submitted
- 15 Mar 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on the requirements from journal where results of this study will be published
Publications
Titova E, Aune MW, Fonn K, Henriksen AH, Asberg A. Neutrophil CD64 Expression as a Diagnostic Marker in Patients Hospitalized with Exacerbations of COPD: A Prospective Observational Study. Lung. 2015 Oct;193(5):717-24. doi: 10.1007/s00408-015-9762-2. Epub 2015 Jul 15.
PubMed 26174093
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calprotectin I in Serum as a Diagnostic Marker of Pneumonia in Patients Hospitalised With Acute COPD Exacerbation
- ClinicalTrials.gov ID
- NCT03474484
- Acronym / sponsor ID
- 20171496/REK midt
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Biomarkers, Sensitivity and Specificity, Clinical Deterioration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lower respiratory tract infection is the most common cause of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Patients diagnosed with pneumonia in addition to an AECOPD experience more severe clinical and laboratory disease manifestations, increase in-hospital morbidity and worse outcome. Clinicians have sought for new biomarkers that together with clinical assessments can improve the diagnostic accuracy of pneumonia in patients with AECOPD.The aim of the present study is to compare the accuracy of calprotectin with procalcitonin (PCT), C-reactive protein (CRP) and white blood cell count (WBC).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| np-AECOPD | – | –Patients with evidence of acute exacerbation of chronic obstructive pulmonary disorder (AECOPD) and pulmonary infiltrate on chest X -ray at admission |
| p-AECOPD | – | –Patients with evidence of acute exacerbation of chronic obstructive pulmonary disorder (AECOPD) without pulmonary infiltrate on chest X -ray at admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Department of Thoracic Medicine at Trondheim University Hospital (TUH) due to an AECOPD, age > 18years old. (EU). The patients were examined at the Emergency Unit and included in the study if they had a COPD diagnosis previously confirmed by spirometry according to the GOLD criteria and a clinically confirmed AECOPD
Key inclusion criteria (2 listed)
- clinically confirmed acute exacerbation of chronic obstructive pulmonary disorder (AECOPD)
- COPD diagnosis previously confirmed by spirometry according to the GOLD criteria.
Key exclusion criteria (5 listed)
- known malignant disease
- bronchiectasis
- chronic bacterial colonisation of the airways
- treatment with an immunosuppressive drug or long-term treatment with antibiotics.
- not examined with a chest X-ray at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calprotectin concentration in serum
Time frame: Change in serum concentration from baseline to 48 hours
ELISA-kit (MRP8/14 ELISA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Background: PubMed 26174093Titova E, Aune MW, Fonn K, Henriksen AH, Asberg A. Neutrophil CD64 Expression as a Diagnostic Marker in Patients Hospitalized with Exacerbations of COPD: A Prospective Observational Study. Lung. 2015 Oct;193(5):717-24. doi: 10.1007/s00408-015-9762-2. Epub 2015 Jul 15.
- Individual participant dataSharing planned: Undecided. Depending on the requirements from journal where results of this study will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne h. Henriksen, md phd study director
St Olavs Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calprotectin concentration in serum (time frame: Change in serum concentration from baseline to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03474484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.